Argus PB-3000
The ARGUS PB-3000 is described as a vital-data acquisition unit used within or connected to a host medical device or system. It receives patient signals from external sensors and…
The ARGUS PB-3000 is described as a vital-data acquisition unit used within or connected to a host medical device or system. It receives patient signals from external sensors and communicates with the host.
The filing says data is sent to the host over a network connection without storing vital or demographic data on the PB-3000. Depending on variant, modules support ECG, respiration, invasive blood pressure, temperature, cardiac output, SpO2, CO2, or non-invasive blood pressure.
Listed Item
“The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital date of a patient: ECG and Respiration ECG, heart rate, asystole time, respiration rate and apnoea time for monitoring and diagnostic purpose. IBP The IBP measurement is intended for continuously invasive measurement of a patient’s arterial and/or venous blood pressure in different locations. NIBP The NIBP measurement is intended for non-invasive measure blood pressure with different cuffs in different locations. SpO2 The SpO2 measurement is intended for non-invasive measuring of a patient’s oxygen saturation level and other parameters (e.g. SpCO, SpMet). CO2 and Respiration The CO2 measurement is intended for the non-invasive monitoring of a patient’s in and exhaled carbon dioxide, anaesthesia gases and to provide a respiration rate. Cardiac Output (CO) The Cardiac Output measurement is intended for measuring continuously blood and injected fluid temperature for calculating the current Cardiac Output of a patient in the medical system (Host System). Temperature The Temperature measurement is intended for non-invasive and invasive measurement of a patient’s temperature in different locations.”
Data Flow and Configuration
The filing says the third-party host-system manufacturer chooses which PB-3000 variant to implement in its host system.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Schiller AG, Switzerland |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K221056 |
| Record published | 2023-09-04 |
| Record revised | 2024-09-13 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -10 to 50 °C; Storage environment temperature 5 to 50 °C; Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PB-3000 Var.7, sub-variant: SAG | In distribution | |
| PB-3000 Var.9, sub-variant: LB | In distribution | |
| PB-3000 Var.3, sub-variant: SAG | In distribution | |
| PB-3000 Var.1, sub-variant: S | In distribution | |
| PB-3000 Var.8, sub-variant: Q | In distribution | |
| PB-3000 Var.1, sub-variant: SAG | In distribution | |
| PB-3000 Var.5, sub-variant: SAG | In distribution | |
| PB-3000 Var.7, sub-variant: M/I | In distribution | |
| PB-3000 Var.6, sub-variant: SAG | In distribution | |
| PB-3000 Var.2, sub-variant: SAG | In distribution | |
| PB-3000 Var.2, sub-variant: S | In distribution | |
| PB-3000 Var.10, sub-variant: M/I | In distribution | |
| PB-3000 Var.5, sub-variant: S | In distribution | |
| PB-3000 Var.4, sub-variant: SAG | In distribution | |
| PB-3000 Var.7, sub-variant: C | In distribution | |
| PB-3000 Var.9, sub-variant: Q | In distribution | |
| PB-3000 Var.7, sub-variant: S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221056 | 2023-07-06 |
| K101619 | 2010-11-12 |
| K053207 | 2006-05-19 |
| K012226 | 2002-04-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Schiller AG | 510(k) number | 2025-08-08 | Class II | Nonconforming Material/Component | Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range. | 266 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.